Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

Recall Number: D-0876-2026

Firm: Par Health USA, LLC

Classification: Class II

Status: Ongoing

Report Date: 20261007

Initiation Date: 20260908

Termination Date:

Reason for Recall

Crystallization

Product Description

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05